Sr. Specialist, Document Management & Training

Responsibilities

Support day-to-day Document Control and Training processes.
Oversee and assist with development and implementation of controlled documents including, but not limited to: SOPs, Work Instructions, training materials, protocols, reports, templates, and reference guides.
Ensure documents meet GMP, Good Documentation Practice, enterprise formatting, and authoring standards.
Collaborate with department managers to develop training requirements and training plans in the eLMS.
Administer the Learning Management System (LMS), including assignment, tracking, and reporting of training curricula.
Coordinate training assignments related to new or revised documents.
Oversee and support generation of compliance metrics and routine KPI reports for Document Control and Training processes.
Support inspection readiness initiatives for Document Control and Training processes.
Train GxP personnel on documentation and training practices within the eDMS and eLMS.
Identify gaps or trends in document control and training compliance and recommend improvements.
Build and maintain relationships with other departments and establish a culture of engagement and transparency with Quality.
Participate in system validation activities, as required.
Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
Perform other duties, as assigned.

Qualifications

Bachelor’s degree in Computer Science, Life Science or related field or applicable experience.
4+ years in Quality Systems/Quality Assurance experience in the regulated life sciences industry.
Experience in the use of validated computer systems for management of regulated documents and training, including electronic records and electronic signatures.
Thorough knowledge of electronic Quality Management Systems, Learning Management Systems and Quality Documentation Systems, admin experience strongly desired.
Experience with Dot Compliance, preferred.
Experience developing improvements to electronic Quality Systems.
Strong software proficiency with Microsoft Suite and other desktop applications.
Ability to manage multiple projects in a dynamic environment with attention to detail.
A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
Excellent written and verbal communication and collaboration skills with the ability to interact with all levels throughout the organization.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.